A Study of VRG50635 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of VRG50635 in Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06286475
• Other study ID #: VGCS-50635-003
• Status: Recruiting
• Phase: Phase 1
• Start date: February 29, 2024
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: Verge Genomics
• Contact: Verge Genomics
• Phone: Please Email
• Email: clinicaltrials[@]vergegenomics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objectives of this study are to investigate the safety and tolerability of VRG50635 and to determine how VRG50635 is absorbed by the body.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

• Must have a body mass index = 18.5 and = 32 kilogram per square meter (kg/m2) and weigh = 50 kg.
• Participants of childbearing potential are eligible to participate if they are not pregnant or breastfeeding and agree to use 1 highly effective and 1 barrier method of contraception, if sexually active, for the duration of the study through 90 days after the last study drug administration. Participants must not donate eggs for the duration of study through 90 days after the last dose of study drug.
• Participants capable of producing sperm must agree that they will use 1 barrier method of contraception and that their partners of childbearing potential will use 1 highly effective method of contraception for the duration of the study through 90 days after the last study drug administration. Participants must not donate sperm for the duration of study through 90 days after the last dose of study drug.

Exclusion Criteria:

• Have a history of clinically significant hematologic, renal, neurologic, pancreatic, gastrointestinal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, immunological, allergic disease, or other major disorders, as determined by the principal investigator (PI).
• Have any surgical or medical condition that could possibly affect drug absorption (including inflammatory bowel disease, history of gastrectomy, cholecystectomy, or other gastrointestinal tract surgery except appendectomy).
• Have a current significant medical or psychiatric condition, as determined by the PI. Other protocol-defined criteria apply.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• VRG50635
Specified dose on specified days
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
United States	Site 001	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Verge Genomics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events		Up to Day 30
Primary	Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUCinf)		Up to Day 16
Primary	Area Under the Concentration-time Curve from Time 0 to the Last Measurable Concentration (AUClast)		Up to Day 16
Primary	Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-dose (AUC0-24)		Up to Day 16
Primary	Area Under the Concentration-time Curve Between Consecutive Doses (AUCtau)		Up to Day 16
Primary	Maximum Observed Concentration (Cmax)		Up to Day 16
Primary	Half-life (t1/2)		Up to Day 16
Primary	Time of Maximal Plasma Concentration (tmax)		Up to Day 16